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U.S. Department of Health and Human Services

Class 2 Device Recall Everflex SelfExpanding Peripheral Stent with Entrust Delivery System

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  Class 2 Device Recall Everflex SelfExpanding Peripheral Stent with Entrust Delivery System see related information
Date Initiated by Firm November 03, 2017
Create Date November 29, 2017
Recall Status1 Terminated 3 on September 01, 2020
Recall Number Z-0188-2018
Recall Event ID 78570
PMA Number P110023S012 
Product Classification Stent, superficial femoral artery - Product Code NIP
Product Everflex Self-Expanding Peripheral Stent with Entrust Delivery System
Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.
Code Information Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328.   Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.
Recalling Firm/
Manufacturer		 Medtronic Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact Krystin Hayward
508-261-8000
Manufacturer Reason
for Recall		 Stent length on the label may not match the length of the stent itself.
FDA Determined
Cause 2		 Employee error
Action Medtronic sent an Urgent Medical Device Recall letter on approximately 11/03/2017, via UPS 2-day delivery. Instructions include identify and quarantine all unused affected product in inventory, return all unused affected product, and complete and return the Customer Confirmation Certificate. Customers with questions regarding this communication, please contact your Medtronic Field Representative. For questions regarding this recall call 508-261-8000.
Quantity in Commerce 21 units
Distribution Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NIP and Original Applicant = MEDTRONIC VASCULAR INC
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